Method of incorporating a thread in wavy formin a gauze surgical dressing



Dec. 28, 1954 IN V EN TOR. A2 50 A5424 M5516.

United States Patent METI-IGD OF'INCORPORATIN G -A THREAD IN WA-VY FORMIN A GAUZE SURGICAL DRESSING Application July 315, 1952 Serial No.299,043 9 Claims. {(1154-93) "This invention is directed to improvementsin surgical sponges or the like.

*In'certain'classes of surgical operations, and particularly inabdominal surgery, it is common practice to-pack the wound cavity withabsorbent pads or sponges.

In the course of an operation many such pads are used, antlzit-isdifficult, if not impossible, to keep track of the exact number ofsponges employed, inasmuch as such a check as maybe made is notaltogether accurate, and as frequently happens, the operating surgeonremalns 1n doubt as to whether all such pads used were finally removed.It is not infrequent that due to the surgeons undivided attentionfocused on the delicate problems before him, he must ,depend to a greatextent on the fsponge count, as performed by ,the other members of theoperating team. "In an emergency operation where a time factor isinvolved and in which case all surgical procedure must cease .and theincision be closed, it is of paramount importance that asponge count,and a check of all surg cal paraphernalia be made, prior to, and afterall such surgical operations.

However, the possibility of the humanerror must always be considered,and as previously mentioned, the surgeon ,mayremain in ,doubt and resortmust be made to X-ray. or equivalent inan effort to determine thepresence of aforeignbody remaining within the patient.

Hence, the principal object ,of the present invention is to provide amethod for preparing a telltale absorbent pad orsponge which, ifinadvertently lost in the wound, would, due to combining a sinuous radioopaque material with an ordinary surgical pad or sponge, be accuratelylocalized by the X-ray machine. It would be quite a simple matter inmany cases to take an X-ray film if there is ques tion of doubt duringthe temporary closing-of the incision, usually held closed by surgicalclamps. Such a check would disclose the sponge, thus rendering it aneasy matter to reopen the 1ncision and remove .the pad with the leastpossible risk to the patient. However, if the foreign matter is .notradlo opaque, as :is the :case in ordinary gauze pads or sponges, itwill be necessary .during postoperative diagnosis to determine byphysical signs and symptoms of the patient whether a sponge may havebeen lost, and just where in the wound an attempt should be madetorecover it.

Another object of this invention is to provide an improved method forpreparing a telltale absorbent pad or sponge with a tracer having meansresponsive to X-ray or an equivalent, which may be placed within thepad, or on itsexterior or-integrated with the pad in such a way as notto impair the necessary softness of the pad and in no way interfere withits swabbing or sponging properties, and which on exposure would cast adistinctive shadow or pattern easily discernible from the organs in thebody.

Various other objects, invention will be apparent from the followingdescription and from inspection of the accompanying drawings, in which--Fig. 1 shows a face view of a section of gauze, having adhesivelyattached thereto a tracer of radio opaque material which when foldedforms a completed surgical pad or sponge;

'Fig. 2 shows in tially folded;

Fig. .3 is a perspective view of a completed pad;

Fig. 4 is a perspective view similar to Fig. 3 but showingythereverseside thereof;

perspective the elements of Fig. 1 parpresence and position of a lostpad or features and advantages of the- Fig. 5 is a diagrammatic viewshowing .the invention method of applyingzthe opaque material tothegauze strip.

Referring to Figs. .1, 2, 3, 4 and 5 of .thedrawings, the pad or sponge10, which otherwise may be as usual, is provided with anzelement orelements, which whenin pad formas illustratedin Figs. 3 and 4, andinadvertently-left ina .Woundof the patient, will be responsive to.X-ray, and will :always appearon the X-ray plate in an unmistakablecriss-crossof ripple wave patterns covering a wide area on ithe X-rayplate regardless of the angle from which the picture is taken. As shown:bestin Fig. l, a sinuous thread, preferably a monofilament 121'semployed, suitably the same length as the unfolded-gauze section 14 andsymmetrical thereto along a centerfold line 18.

The sinuous thread ormonofilament 12 described more fully below, asemployed in this invention, comprises an elastomer loaded with an X-rayopaque material. The elastomer is'any natural or synthetic plastic whichhas, or maybe compounded to have, flexible'or elastic rubber-likeproperties, including freedom from tack at normal temperatures. Themonofilament is preferably anchored vby adhesion to the surgicalmaterial, such as cotton gauze, by sealing thereto with heat, or othersuitable means, use of heat being preferred.

The method of the present invention which affords easily controlledoperation, consistent results, and a ripple wave pattern of thread,preferably monofilament, having substantially uniform sinuousconfiguration is illustrated in Fig. 5. A'continuous monofilament 30withdrawn from a supply notshown is passed over guide roll 32 and on tothe lower peripheral portion of rotating roll 42, which rotates in acounter-clockwise direction. The portion .of n1ono'filament'30 betweenrolls 32 and 42 is preferably in an untensioned, substantially relaxedcondition. A continuous strip of surgical gauze 34 is drawn from spool36 andthence on to the bottom peripheral portion of roll 42.monofilament 3.0. Gauze supply roll form and controllable tension ongauze strip 3421s itcontacts and passes around roll 42. .Superjacentroll/ll) is heated. Rolls 40 and 42, which rotate ,at the same speed,may be mechanically driven or may be driven by the gauze pulled throughthem. The tensioned gauze strip 34 passes around roll 42, holdingmonofilament 30 lightly against roll 42 but with sufiicient force touniformly restrict substantially but yieldingly sidewise or longitudinalmovement of the vmonofilament. The zone between the point where gauze 34and thread 30 first contact roll 42, and the beginning of nip 41 isdesignated as the preliminary zone since it ,is here that the thread isso placed with relation to the gauze and roll 42 as to be receptive toacquirrig the wavy form from subsequent treatment in mp At the pointwhere gauze and monofilament start to warp .around roll 42, the tensionof the gauze around the roll holds the monofilament against the roll,causing the monofilament and the gauze to feed into the nip 41 at thesame ratemeasured tangentially at the nip of the roll, the heat .andpressure cause the gauze and monofilament to combine. The region wherethe gauze and thread are squeezed in the nip between rolls 40 and 42 istermed a pressuring zone. However, the monofilament elongates as ,it isforced between the rolls, higher temperatures tending to produce moreelongation of filament. The excess length of monofilament caused by thiselongation produces backing up of the monofilament. However, theconfining action of gauze web 34 as it presses against roll 42 restrictsmovement of the monofilament and thereby produces a wave-like pattern ofsinuous configuration therein.

The monofilament is sealed to the gauze in the form of this wavypattern. The amplitude and frequency of the wavy pattern formed isdetermined by the amount of elongation and the tightness of the gauzewrapped around roll 42. When the gauze is extremely tight, this excessmonofilament can work its way back a relatively short distance, and awave of small amplitude butof high frequency is formed. As the tensionof the gauze around roll 42 is relaxed, the excess monofilament can workits way further back around the periphery of the roll forming a wavewith greater amplitude but with less 3 frequency. Higher elongationstend to produce a wave of higher amplitude. Experience has shown thatwith a tension of less than 2 lbs. per inch width on the gauze, themonofilament will not generally be fed around the roll at the sameperipheral speed as the gauze. Hence, the excess monofilament may workits way completely around the roll, and periodic straight lines mayappear in the filament. The tension on the gauze may be increased withthe resultant decrease in amplitude and increase in frequency of thewave pattern up to the point where the gauze will break because of toohigh tension. In actual practice it was found that tensions up to aboutlbs. per inch are acceptable from the point of view of avoiding gauzebreakage and obtaining a wavy pattern having satisfactorily highamplitude. A tension of approximately 3 to 8 lbs. provides aparticularly desirable pattern and hence is preferred.

By controlling the tension in gauze 34 and the temperature of roll 40,the amplitude and frequency of the wave pattern may be controlled asdesired. An important aspect of the invention is controlling conditionsto produce a wave of uniform characteristics. In passage from nip 41 tothe top peripheral portion of roll 40, the sealing of monofilament 30 togauze 34 is completed. Bottom roll 42 is preferably unheated.

From rolls 40 and 42 the gauze strip 34 containing the wave-formmonofilament 30 is fed into a cut-off knife 46. Not shown is a devicefor folding the gauze strip section 14 containing the monofilament, asbest seen in Fig. 1, into surgical pads or sponges, usually intosquares.

In producing a wave-like monofilament in which the waves have uniformamplitude, there is notable advantage in employing a monofilament havinga substantially circular cross-section. Accordingly, a preferredembodiment of the invention includes the use of a round monofilament.However, the invention is not limited to a round monofilament. The useof oval or flat monofilaments according to the present invention affordsa method having important advantages over other methods. A filament offrom 17 to 20 mils is utilized; carbon black present in said filament isto color the filament for visual detection. The X-ray opaque materialmay be any of a number of such materials as barium, strontium, thorium,lead, tungsten, etc., or compounds thereof, so long as they are nottoxic; but barium sulphate has been found to be particularlyadvantageous. This material is in a finely divided or powdered statewhen incorporated into filament 12.

Considering further the cut section of gauze having the sinuous filamentsealed thereto, and with particular reference to Fig. 1, it will be seenthat by folding the end portions of the gauze section 14 along foldlines 16 towards the center and again folding the gauze from left toright or right to left along the center fold line 18, we are now readyfor the final folding operation along fold line 20 (see Fig. 2) in thetransverse direction from the previous lines of fold. This forms a padcontaining a multiplicity of cotton gauze layers, in this particularembodiment eight (8) layers of cotton gauze, in which the elastomericsinuous monofilament is located in four adjacent layers, comprising halfthe pad thickness while the remaining gauze layers are free from thesinuous or ripple wave monofilaments 12. To insure pad 10 from thetendency of fraying edges, the edges of the gauze section 14 as seen inFig. 1, may be turned inwardly as along lines of fold 22.

Referring more specifically to Fig. 4, illustrating that side of thesurgical pad or sponge 10, in which the monofilament 12 is most visible,it will be observed that the entire length of the ripple wavemonofilament 12 is visible through the surgical gauze, crossing andrecrossing upon itself in successive layers, to set up as previouslymentioned, an unmistakable sinuous criss-cross pattern, covering a widearea on the X-ray plate when exposed, thereby making it an easy matterto localize its exact position in the patient.

Other commercially available sponges of similar construction have usedstraight line filaments, but the tendency for the lines to remain insubstantially parallel relationship, or superimposed upon one anotheralways exists, making it less discernible, and more likely to beconfused with muscle structure and other internal organs. The sinuousmonofilament is adapted to overcome such difli' culties in the mannerpreviously stated.

The pad or sponge in the position illustrated in Fig. 4 may be packed toadvantage, one upon another in a carton or package, so that as eachsuccessive pad is removed for use, the topmost pad will be alwaysvisually distinguishable from ordinary pads or sponges.

In the most usual application of this invention the X-ray opaqueelastomeric sinuous monofilament 12 is combined with a gauze pad in theform of from 8 to 16 layers of cotton gauze. The gauze section may be sofolded as to have the sinuous monofilament in alternate layers, but itis preferable to present the elastomer in the outer layers, such as tomake it visually distinguishable from ordinary sponges as previouslystated. The gauze is customarily sterilized before use.

The completed sponge 10 as has been fully described meets therequirements of such material as used in surgery, including X-rayopacity, sterilizability, non-absorbability in body fluids, reasonablecost, visually detectable color, firm anchorage, freedom from abrasionand irritation, non-fraying, and lack of toxicity.

While the invention has been described with particular reference tospecific embodiments, it is to be understood that it is not to belimited thereto, but is to be construed broadly and restricted solely bythe scope of the appended claims.

The claims are:

1. The method of incorporating into a dimensionally web in saidpressuring zone and elongating said thread from said pressuring zoneinto said preliminary zone, whereby said thread is pressed against andsealed onto said web in said pressuring zone, and said thread is inducedto assume a wavy configuration in said preliminary 2. The method ofincorporating into a dimensionally stable web a flexible thread which isnon-tacky at ordinary temperatures but tacky at elevated temperatures inper-' manently wave-like form which comprises feeding said web and saidthread adjacent each other at the same linear speed through apreliminary unheated zone and toward a pressuring zone heated totemperature at which said thread is tacky, yieldingly uniformlyrestricting movement of said thread relative to said web in saidpreliminary zone, passing said web and said thread from said preliminaryzone directly into said pressuring zone, pressing said thread againstsaid Web in said pressuring zone and elongating said thread from saidpressuring zone into said preliminary zone, whereby said thread ispressed against and sealed onto said web in said prestures inpermanently wave-like form which comprises; feeding said web and saidmonofilament adjacent each other at the same linear speed through apreliminary unheated zone and toward a pressuring zone heated totemperature at which said monofilament is tacky, yieldingly uniformlyrestricting movement of said monofilament relative to said web in saidpreliminary zone, passing said Web and said monofilament from saidpreliminary zone directly into said pressuring zone, pressingsaidmonofilament against web in said pressuring zone an elongating saidmonofilament from said pressuring zone into said preliminary zone,whereby said monofilament is pressed against and sealed onto said web insaid pressuring zone, and said monofilament is induced to assume a wavyconfiguration in said preliminary zone.

4. The method of incorporating into a gauze web a flexible roundmonofilament which is non-tacky at normal temperatures but tacky atelevated temperatures in uniform permanently wave-like configurationwhich com prises feeding said gauze and said round monofilament adjacenteach other at the same linear speed through a preliminary unheated zoneand toward a pressuring zone heated at temperature at which saidmonofilament is tacky, yieldingly uniformly restricting movement of saidmonofilament relative to said gauze in said preliminary zone, passingsaid gauze and said monofilament from.

said preliminary zone directly into said pressuring zone,

pressing said monofilament against said gauze in said pressuring zoneand elongating said monofilament from said pressuring zone into saidpreliminary zone, whereby said monofilament is pressed against andsealed onto said gauze in said pressuring zone, and said monofilament isinduced to assume a uniform wavy configuration in said preliminary zone.

5. The method of incorporating into a gauze web a flexible monofilamentwhich is non-tacky at normal temperatures but tacky at elevatedtemperatures in permanently wave-like configuration which comprisesfeeding said gauze and said monofilament adjacent each other at the samelinear speed through a preliminary unheated zone and toward a rotatingroll heated to temperature at which said monofilament is tacky,yieldingly uniformly restricting movement of said monofilament relativeto said gauze in said preliminary zone, passing said gauze and saidmonofilament from said preliminary zone directly between said roll, anda cooperating pressure member, pressing said monofilament against saidgauze in said pressuring zone and elongating said monofilament from saidpressuring zone into said preliminary zone, whereby said monofilament ispressed against and sealed onto said gauze in said pressuring zone, andsaid monofilament is induced to assume a wavy configuration in saidpreliminary zone.

6. A method of producing a gauze surgical dressing comprising an X-rayopaque thread including an elastomer, said thread being afiixed to saiddressing in permanent wave-like configuration, comprising feeding a webof said gauze and said thread at substantially the same linear speed toa preliminary roll-contacting zone on the periphery of a rotating roll,said thread being disposed between the surface of said roll and saidgauze, controlling the tension on said gauze to produce substantial anduniform pressure thereof against the surface of said roll in saidpreliminary roll-contacting zone and thereby uniformly restrictsubstantially but yieldingly sidewise and longitudinal movement of saidthread relative to said gauze in said preliminary roll-contacting zone,continuing rotational movement of said thread and said gauze about saidfirst roll through said preliminary roll-contacting zone and directlyinto the nip between said first roll and a second heated roll, pressingsaid thread and said gauze in said nip to seal said thread to said gauzeand induce backward elongation of said thread relative to said gauze insaid preliminary roll-contacting zone whereby thread in said preliminaryzone is induced to assume a wavy configuration and removing saidthreadsupporting gauze from said nip.

7. A method of producing a gauze surgical dressing comprising an X-rayopaque monofilament including an elastomer, said monofilament beingaffixed to said dressing in permanent wave-like configuration,comprising feeding a web of said gauze and said monofilament atsubstantially the same linear speed to a preliminary rollcontacting zoneon the periphery of a rotating roll, said monofilament being disposedbetween the surface of said roll and said gauze, controlling the tensionon said gauze to produce substantial and uniform pressure thereofagainst the surface of said roll in said preliminary rollcontacting zoneand thereby uniformly restrict substantially but yieldingly sidewise andlongitudinal movement of said monofilament relative to said gauze insaid preliminary roll-contacting zone, continuing rotational movement ofsaid monofilament and said gauze about said first roll through saidpreliminary roll-contacting zone and directly into the nip between saidfirst roll and a second heated roll, pressing said monofilament and saidgauze in said nip to seal said monofilament to said gauze and inducebackward elongation of said monofilament relative to said gauze intosaid preliminary roll-contacting zone whereby monofilament in saidpreliminary zone is induced to assume a wavy configuration and removingsaid monofilament-supporting gauze from said nip.

8. A method of producing a gauze surgical dressing comprising an X-rayopaque monofilament including an elastomer, said monofilament beingaffixed to said dressing in uniform permanent wave-like configuration,comprising feeding a web of said gauze and a round X-ray opaquemonofilament at substantially the same linear speed to a preliminaryroll-contacting zone on the periphery of a rotating roll, saidmonofilament being disposed between the surface of said roll and saidgauze, controlling the tension on said gauze to produce substantial anduniform pressure thereof against the surface of said roll in saidpreliminary roll-contacting zone and thereby uniformly restrictsubstantially but yieldingly sidewise and longitudinal movement of saidmonofilament relative to said gauze in said preliminary roll-contactingzone, continuing rotational movement of said monofilament and said gauzeabout said first roll through said preliminary roll-contacting zone anddirectly into the nip between said first roll and a second heated roll,pressing said monofilament and said gauze in said nip to seal saidmonofilament to said gauze and induce backward elongation of saidmonofilament relative to said gauze in said preliminary roll-contactingzone whereby monofilament in said preliminary zone is induced to assumea uniform wavy configuration, removing said monofilament-supportinggauze from said nip on the periphery of said second roll with rotatingmovement of the roll, and removing said monofilament-supporting gauzefrom the periphery of said second roll.

9. A method of producing a gauze surgical dressing comprising an X-rayopaque monofilament including an elastomer and non-tacky at normaltemperatures but tacky at elevated temperatures, said monofilament beingafiixed to said dressing in permanent wavelike configuration, comprisingfeeding a web of said gauze and said monofilament at substantially thesame linear speed to a preliminary roll-contacting zone on the peripheryof a rotating unheated roll, said monofilament being disposed betweenthe surface of said roll and said gauze, controlling the tension on saidgauze to produce sub stantial and uniform pressure thereof against thesurface of said roll in said preliminary roll-contacting zone andthereby uniformly restrict substantially but yieldingly sidewise andlongitudinal movement of said monofilament relative to said gauze insaid preliminary rollcontacting zone, continuing rotational movement ofsaid monofilament and said gauze about said first roll through saidpreliminary roll-contacting zone and directly into the nip between saidfirst roll and a second roll heated to temperature at which saidmonofilament is tacky, pressing said monofilament and said gauze in saidnip to seal said monofilament to said gauze and induce backwardelongation of said monofilament relative to said gauze in saidpreliminary roll-contacting zone whereby monofilament in saidpreliminary zone is induced to assume a wavy configuration and removingsaid monofilament-supporting gauze from said nip.

References Cited in the file of this patent UNITED STATES PATENTS NumberName Date 1,424,020 Hopkinson July 25, 1922 2,190,431 Lewison Feb. 13,1940 2,321,512 Protz June 8, 1943 2,539,690 Boorn Jan. 30, 1951

1. THE METHOD OF INCORPORATING INTO A DIMENSIONALLY STABLE WEB AFLEXIBLE THREAD IN PERMANENTLY WAVE-LIKE FORM WHICH COMPRISES FEEDINGSAID WEB AND SAID THREAD ADJACENT EACH OTHER AT THE SAME LINEAR SPEEDTHROUGH A PRELIMINARY ZONE AND TOWARD A PRESSURING ZONE, YIELDINGLYUNIFORMLY RESTRICTING MOVEMENT OF SAID THREAD RELATIVE TO SAID WEB INSAID PRELIMINARY ZONE DIRECTLY INTO AND SAID WEB IN SAID PRELIMINARYZONE, PASSING SAID WEB SAID PRESSURING ZONE, PRESSING SAID THREADAGAINST SAID WEB IN SAID PRESSURING ZONE AND ELONGATING SAID THREAD FROMSAID PRESSURING ZONE INTO SAID PRELIMINARY ZONE WHEREBY SAID THREAD ISPRESSED AGAINST SAID SEALED ONTO SAID WEB IN SAID PRESSURING ZONE, ANDSAID THREAD IS IN-